MediMax Tech - MXF43RW-5 ECG: PE Foam, Wet Gel, Universal Round - MEDIMAX TECH INC.

Duns Number:927071162

Device Description: MXF43RW-5 ECG: PE Foam, Wet Gel, Universal Round 43mm ECG Electrode, 5pcs/Pack, 100pcs/Box MXF43RW-5 ECG: PE Foam, Wet Gel, Universal Round 43mm ECG Electrode, 5pcs/Pack, 100pcs/Box, 1000pcs/Master Case

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More Product Details

Catalog Number

-

Brand Name

MediMax Tech

Version/Model Number

MXF43RW-5 ECG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K083148,K083148,K083148

Product Code Details

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Device Record Status

Public Device Record Key

4008f42b-7d9c-45a3-b24d-b9d16b853598

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 18, 2016

Additional Identifiers

Package DI Number

20817325022310

Quantity per Package

10

Contains DI Package

10817325022313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"MEDIMAX TECH INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 309